Xarelto (rivaroxaban) is a blood thinner that was approved by the U.S. Food & Drug Administration (FDA) in July 2011 to prevent strokes in patients who received hip and knee replacements. In November 2011, the approval was expanded to any patients with atrial fibrillation (irregular heartbeat). Xarelto has been widely prescribed, with millions of people taking the medication since it entered the market.

The number of lawsuits alleging injuries associated with ingestion of Xarelto continues to grow in the United States. Regulators in Canada recently announced investigations into reports of liver injuries that may be associated with Xarelto usage. The August 26 safety review cites numerous reports of liver injuries among Xarelto users. The Canadian government will continue to monitor the safety information involving Xarelto to assess the health risks of the medication.